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FDA 510(k)

DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUM

K-Number: K122955 · 2013-03-01

ApplicantWright Health Group , Ltd.
Decision Date2013-03-01
Product CodeELM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUM is the device name listed in this FDA 510(k) record. The listed applicant is Wright Health Group , Ltd.. It received FDA 510(k) clearance on 2013-03-01 under 510(k) number K122955. The device is classified under product code ELM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUM?

DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUM is a medical device that received FDA 510(k) clearance on 2013-03-01. The listed applicant is Wright Health Group , Ltd.. The 510(k) number is K122955.

When did DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUM receive FDA 510(k) clearance?

DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUM received FDA 510(k) clearance on 2013-03-01, under 510(k) number K122955.

Who is the listed applicant for DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUM?

The FDA 510(k) record lists Wright Health Group , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUM?

The FDA product code for DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUM is ELM.

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Related Devices (Code: ELM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K122925NEW STETIC ARTIFICIAL TEETHNew SteticK122852PHYSIOSTAR NFCCandulor USA, Inc.K121749VERACIAShofu Dental CorporationK120404MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETHMerz Dental GmbHK120736SR PHONARES IIIvoclar Vivadent, AGK113426VERACIA SAShofu Dental Corporation

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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